Description

Imipenem Impurity CAS NO 776257-75-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Imipenem by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on quality control and method development in antibiotic production.

Application

• Pharmaceutical Quality Control (QC): Primary standard for the identification and quantification of impurities in Imipenem active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a reference marker to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Regulatory Compliance and Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing characterized impurity standards for specification setting.
• Stability Studies: Employed to monitor the formation of degradation products in Imipenem formulations under various stress conditions.
• Research and Development (R&D): Serves as a critical tool in synthetic chemistry R&D to understand and control impurity formation during the Imipenem manufacturing process.
• Contract Research Organization (CRO) Services: Essential reference material for third-party testing and analysis services offered to pharmaceutical clients.

Basic Information

Product Name	Imipenem Impurity
CAS No.	776257-75-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5R,6S)-2-[(3S,5S)-5-[(Dimethylcarbamoyl)pyrrolidin-3-yl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Imipenem Related Compound; Imipenem Impurity Standard; Imipenem EP Impurity; Imipenem USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Imipenem Impurity CAS NO 776257-75-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.